Targeted Nutrition for Moderate to Late Preterm Infants

February 21, 2025 updated by: Loma Linda University
This study will be comparing the postnatal growth of moderate to late preterm infants in the Neonatal Intensive Care Unit (NICU) born between gestational ages of 30 weeks 0 days to 35 weeks and 6 days who are receiving enteral feeds of mother's own breast milk using the NICU's standard nutritional fortification protocol versus a targeted nutritional fortification protocol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infants in the NICU born between gestational ages 30 weeks 0 days and 35 weeks 6 days will be screened to determine if they are receiving unfortified mother's breast milk for enteral nutrition. Informed consent will be obtained from these lactating mothers for themselves and their infants to participate in the study. Once enrolled in the study, the mother and infant dyad will be randomized using an electronic tool for block randomization into standard fortification arm (control group) or targeted fortification arm (intervention group). Maximum of 100 infants will be assigned to each arm to ensure statistical significance. The physician team, study statisticians, and the mothers will be blinded in their group assignment.

Mothers will be provided with one-on-one teaching (with verbal and written instructions) by the NICU certified lactation consultants or by an authorized, trained study personnel on how to pool their pumped breast milk for 24 hours, referenced as "breast milk pooling." They will also be shown how to prepare a 10 mL sample of the pooled breast milk for analysis. Pooled breast milk will be analyzed for macronutrient content (protein, carbohydrate, fat, and calories) using Miris Human Milk Analyzer before fortification once a week for both arms of the study. All infants in both groups will follow the enteral feeding advancement schedule until the infant is ready for nutritional fortification.

In the standard fortification arm (control group), mother's breast milk will be fortified using Enfamil Liquid Human Milk Fortifier (LHMF) as per standard feeding protocol defined by Loma Linda University Children's Hospital Neonatal Intensive Care Unit. The feeding protocol, specific to birth weight, is available online in the LLUCH NICU Manual.

In the targeted fortification arm (intervention group), mother's breast milk will be fortified in modular fashion. For protein supplementation, Amino Acid powder will be utilized as a modular component. For carbohydrate supplementation, PolyCal will be utilized. For lipid supplementation, safflower oil will be utilized. Fortification goals for this group will follow the macronutrient intake recommendations for preterm infants published by the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition in 2009. The goal energy level will be between 110 - 135 kcal/kg/day, goal protein level between 3.5 - 4.5 g/kg/day, goal lipid level between 4.8 - 6.6 g/kg/day, and goal carbohydrate level between 11.6 - 13.2 g/kg/day. The goal total daily fluid volume will be between 150 to 180 mL/kg/day.

NICU Registered Dietitians will be provided with the macronutrient contents of pooled breast milk from mothers of babies in the intervention group. Using the aforementioned values from ESPGHAN guideline for each macronutrient, they will provide recommendations on specific amounts of modular supplementation to be added to the pooled breast milk. Based on these recommendations, all un-pooled expressed breast milk of mothers in the intervention group will be fortified in a customized manner by the milk technicians in the NICU milk room and given to infants in the intervention group. NICU Registered Dieticians will not be provided with analysis results showing macronutrient levels of the pooled milk or standard fortified milk in the control group as the current standard of care at LLUCH NICU does not include macronutrient analysis of pooled breast milk for babies born >30 weeks gestation.

Infants enrolled in both arms will have their anthropometric measurements taken once a week from birth to NICU discharge. Anthropometric measurements will include weight, height, and head circumference. The Z-scores of weight, height, and head circumference will be recorded and analyzed for any statistical differences.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Singleton preterm infants
  • Between 30 weeks 0 days and 35 weeks and 6 days
  • Receiving any amount of mother's breast milk as a form of enteral nutrition
  • Mother is ≥ 18 y/o

Exclusion Criteria:

  • Not receiving any breast milk
  • Congenital anomalies or surgical conditions that interfere with enteral feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Fortification
Mother's breast milk will be fortified using Enfamil Liquid Human Milk Fortifier (LHMF) as per standard feeding protocol defined by LLUCH NICU.
Dietary supplement: Enfamil Liquid Human Milk Fortifier
Mother's breast milk will be fortified using Enfamil Liquid Human Milk Fortifier as per standard feeding protocol defined by LLUCH NICU manual.
Other Names:
  • LHMF
Experimental: Targeted Fortification
Mother's breast milk will be fortified with modular additives, namely Amino Acid powder, PolyCal, and safflower oil to meet the individual nutritional needs.
Dietary supplement: Targeted Fortification
Mother's breast milk will be fortified in modular fashion based on the level of macronutrients (protein, carbohydrate, and fat) found from analysis using the Miris Human Milk Analyser. For protein supplementation, Amino Acid powder will be utilized as a modular component. For carbohydrate supplementation, PolyCal will be utilized. Mother's breast milk will be fortified in modular fashion. For protein supplementation, Amino Acid powder will be utilized as a modular component. For carbohydrate supplementation, PolyCal will be utilized. For lipid supplementation, safflower oil will be utilized. We will set our goal energy level between 110 - 135 kcal/kg/day, protein level between 3.5 - 4.5 g/kg/day, lipid level between 4.8 - 6.6 g/kg/day, and carbohydrate level between 11.6 - 13.2 g/kg/day. We will regard daily fluid volume to be between 150 to 180 mL/kg/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postnatal growth in weight
Time Frame: From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Weight in kilograms
From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Postnatal growth in length
Time Frame: From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Length in centimeters
From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Postnatal growth in head circumference
Time Frame: From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Head circumference in centimeters
From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Protein level in mother's expressed breastmilk
Time Frame: From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Weekly analysis of pooled mother's expressed breast milk to assess for protein level, measured in grams per 100 milliliters
From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Calories in mother's expressed breastmilk
Time Frame: From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Weekly analysis of pooled mother's expressed breast milk to assess for amount of calories, measured in kilocalories per 100 milliliters
From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Fat content in mother's expressed breastmilk
Time Frame: From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Weekly analysis of pooled mother's expressed breast milk to assess for fat content, measured in grams per 100 milliliters
From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Carbohydrate level in mother's expressed breastmilk
Time Frame: From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Weekly analysis of pooled mother's expressed breast milk to assess for carbohydrate level, measured in grams per 100 milliliters
From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Raylene Phillips, MD, Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2022

Primary Completion (Actual)

May 11, 2023

Study Completion (Actual)

May 11, 2023

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 25, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5220169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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